Acupuncture in Chemotherapy-induced Peripheral Neuropathy in Women With Breast Cancer: Acu-CIPN, a Randomized Controlled Multicenter Study
Overview
- Phase
- Not Applicable
- Intervention
- treatment of physician choice, according to the standard of care
- Conditions
- Peripheral Neuropathy
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Enrollment
- 102
- Locations
- 2
- Primary Endpoint
- Reduction of peripheral neuropathy, including neuropathic pain
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
The main purpose of this study is to define whether acupuncture in addition to the treatment of physician choice as per standard of care leads to a greater decrease of neuropathic pain as perceived by women with breast cancer who suffer from chemotherapy-induced peripheral neuropathy. Peripheral neuropathy and neuropathic pain of hands and foots will be assessed by using a Number Rate Scale (NRS scale) and data will be compared between standard of care treatment group and acupuncture in addition to standard of care treatment group.
Detailed Description
Patients with breast cancer diagnosis and taxane-induced peripheral neuropathy since at least 1 week (CTCAE4.0 Grade 1-3 and NRS≥4) will be enrolled. Patients will be randomized 1:1 in the 2 treatment arms: treatment of physician choice as per standard of care vs acupuncture in addition to standard of care treatment. In experimental arm acupuncture will be performed twice a week for 6 weeks, for a total of 12 sessions. Peripheral neuropathy symptoms and pain at hands and foot will be recorded every day by patients by use of NRS scale. At baseline and every 3 weeks patients will complete CIPN20, EORTC QL30, SF-36 and BPI in order to compare the course of neuropathic pain and quality of life in the 2 arms.
Investigators
Claudio Zamagni MD
MD
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Eligibility Criteria
Inclusion Criteria
- •Female patients ≥18 years.
- •Patients with diagnosis of breast cancer (stage I-III) currently receiving taxane-based chemotherapy (paclitaxel or docetaxel) in neoadjuvant or adjuvant setting, or who have completed taxane-based chemotherapy for no more than 6 months. Concomitant treatment with trastuzumab is allowed in HER-positive patients and/or hormone therapy in patients with hormone-sensitive breast cancer.
- •Chemotherapy-induced peripheral neuropathy graded 1-3, according to NCICTCAE v 4.03 criteria, for at least one week and for no more than 6 months after the completion of chemotherapy regimen.
- •Neuropathic pain with ≥4 points in the numeric scale rate for at least one week
- •Informed consent signed before any study-specific procedure
Exclusion Criteria
- •Patients with diagnosis of metastatic breast cancer
- •Pre-existing peripheral neuropathy in the 28-day period before the start of chemotherapy
- •Any pre-existing condition which can both lead to or be a concomitant factor for neuropathy onset, such as not controlled diabetes mellitus, paralysis, multiple sclerosis, AIDS and Herpes Zoster
- •Patients with amputation and/or severe peripheral vascular disease (peripheral revascularization interventions needed, AOCP\> stage II, rheumatologic disorders affecting arteriole or microcirculation)
- •Patient with history of spinal cord surgery
- •Patient with history of chronic alcoholism
- •Concomitant use of pharmacological agents which can cause neuropathic pain as an adverse event, except for chemotherapy
- •Patient who already experienced acupuncture for any condition
- •Patient currently in treatment with duloxetine, gabapentin, pregabalin or other drugs for the treatment of neuropathic pain
- •Patient with history of psychiatric disorders before breast cancer diagnosis (major depressive disorders, bipolar disorder, suicidal tendency)
Arms & Interventions
Arm A
Treatment for peripheral neuropathy (including neuropathic pain), according to the standard of care (e.g. "Cetirizine", "Gabapentin"). Patient will be followed-up as per protocol for a total of 9 weeks .
Intervention: treatment of physician choice, according to the standard of care
Arm B
In addition to the treatment for peripheral neuropathy and neuropathic pain, according to the standard of care (e.g. "Cetirizine", "Gabapentin"), patient will receive acupuncture administration twice a week and for a 6-week treatment period. Patient will also be followed-up for 3 weeks after the end of treatment.
Intervention: Acupuncture
Arm B
In addition to the treatment for peripheral neuropathy and neuropathic pain, according to the standard of care (e.g. "Cetirizine", "Gabapentin"), patient will receive acupuncture administration twice a week and for a 6-week treatment period. Patient will also be followed-up for 3 weeks after the end of treatment.
Intervention: treatment of physician choice, according to the standard of care
Outcomes
Primary Outcomes
Reduction of peripheral neuropathy, including neuropathic pain
Time Frame: 6 weeks after the start of treatment
Reduction of peripheral neuropathy, including neuropathic pain (at least 3 points on the numeric scale rate) after the 6-week treatment period versus before the start of treatment, greater in the experimental than in the control arm.
Secondary Outcomes
- Improvement of peripheral neuropathy, including neuropathic pain, EORTC QLQ-CIPN20/QLQ-C30 questionnaires(at 3, 6, 9 weeks after the start of treatment)
- Reduction of peripheral neuropathy, including neuropathic pain(at 3 and 6 weeks after the start of treatment)
- Improvement of the quality of life, SF-36 questionnaire(6 weeks after the start of treatment)
- Improvement of peripheral neuropathy, including neuropathic pain, BPI questionnaire(6 weeks after the start of treatment)
- Improvement of peripheral neuropathy, including neuropathic pain, NCICTCAE v 4.03 criteria(at 3, 6, 9 weeks after the start of treatment)
- Type and frequency of adverse events occurrence due to acupuncture(at last visit, 9 weeks from start of treatment)